Data / Medical devices / France / Phakos
Phakos: FDA-registered device maker in Montreuil Seine-Saint-Denis, France, 5 510(k) clearances
Phakos is registered with the FDA (registration 3006142778) in Montreuil Seine-Saint-Denis, France. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 2, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006142778
- Address
- 62 rue kleber, Montreuil Seine-Saint-Denis, France, 93100
- Owner or operator
- PHAKOS (10024840)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 26, 2008
- Registered through
- 2026
- Brand names listed
- Cryomaster I Cryoprobe Adapter, Cryomaster II Cryoprobe Adapter, Disposable Vitrectomy Lenses, Dorc Classic Cryoprobe Adapter, Dorc Cryostar Cryoprobe Adapter, Erbe / Optikon Cryoprobe Adapter, Frigitronics Cryoprobe Adapter, Keeler ACU/CTU Cryoprobe Adapter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Ophthalmic | HMX | 1 | Manufacturer | accessdata.fda.gov |
| Clip, Iris Retractor | HOC | 1 | Manufacturer | accessdata.fda.gov |
| Lens, Contact, Polymethylmethacrylate, Diagnostic | HJK | 2 | Specification developer | accessdata.fda.gov |
| Unit, Cryophthalmic, Ac-Powered | HRN | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 2, 2020 | K200911 | MIRA Adapter | HRN | Substantially Equivalent | Phakos | accessdata.fda.gov |
| October 25, 2018 | K173944 | Endocular Viewing Lenses and Silicone Ring | HJK | Substantially Equivalent | Phakos | accessdata.fda.gov |
| March 16, 2018 | K180195 | Frigitronics adapter | HRN | Substantially Equivalent | Phakos | accessdata.fda.gov |
| May 3, 2017 | K162756 | PHAKOS Disposable Retinal Cryo Probe | HRN | Substantially Equivalent | Phakos | accessdata.fda.gov |
| August 24, 2001 | K012096 | DISPOSABLE VITRECTOMY LENS | HJK | Substantially Equivalent | Ocular Instruments, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Lens, Contact, Polymethylmethacrylate, Diagnostic
- All makers of Clip, Iris Retractor
- All makers of Unit, Cryophthalmic, Ac-Powered
- All makers of Cannula, Ophthalmic
Updated June 2, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.